Portable Driving Simulator for Neurological Conditions

Overseen By Abiodun E Akinwuntan, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Kansas Medical Center

Disqualifiers: Traumatic brain injury, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new portable driving simulator designed to help individuals with neurological conditions such as stroke, Parkinson's disease, or multiple sclerosis improve their driving skills. The researchers aim to determine if this simpler, low-cost simulator can match the effectiveness of a more complex one in helping users maintain lane position, follow speed limits, and react to traffic signals, all without causing simulator sickness. Participants will use either the new portable simulator or the traditional high-tech one for a total of five hours and undergo assessments before and after the training. This trial suits those who have experienced a stroke, Parkinson's, or MS; hold a valid driver's license with at least three years of driving experience; and meet basic vision and cognitive criteria. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could enhance driving safety for individuals with neurological conditions.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the study team or your doctor.

What prior data suggests that this portable driving simulator is safe for patients with neurological conditions?

Research shows that the Portable Driving Simulator (PDS) under testing is designed for ease of use and affordability. It aims to help individuals with conditions like stroke, Parkinson's disease (PD), or multiple sclerosis (MS) enhance their driving skills. The PDS offers a simpler and cheaper alternative to more advanced simulators.

Studies have found that advanced simulators can sometimes cause simulator sickness, similar to motion sickness, resulting in dizziness or nausea. The new PDS aims to reduce these issues. Early results suggest that the PDS might be easier to use and could cause less simulator sickness than advanced options.

The simple setup of the PDS might lead to fewer side effects for users. However, as this study is still in its early stages, more data is needed to confirm its safety. Participants in the trial might find the PDS a safer option with fewer chances of causing simulator sickness. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the use of a Portable Driving Simulator (PDS) as a novel approach for individuals with neurological conditions like stroke, Parkinson's disease, or multiple sclerosis. Unlike traditional rehabilitation methods, which often emphasize physical therapy and medication, this trial investigates how immersive simulation can enhance cognitive and motor skills crucial for driving. The High Fidelity Fixed-Base Simulator Training offers a more realistic driving experience, potentially leading to better real-world driving skills, while the Low-Fidelity PDS Training provides a more accessible and flexible option. This innovative approach could redefine rehabilitation by offering personalized and scalable solutions to improve the quality of life for those affected by these conditions.

What evidence suggests that the Portable Driving Simulator is effective for retraining driving skills in neurological conditions?

Research has shown that driving simulators can enhance driving skills and brain functions in individuals with neurological conditions such as stroke, Parkinson's disease (PD), and multiple sclerosis (MS). In this trial, participants will train with either the Low-Fidelity Portable Driving Simulator (PDS) or the High Fidelity Fixed-Base Simulator. Studies suggest that the PDS may be as effective as more advanced simulators in helping patients regain skills like lane-keeping and speed control. The PDS is also designed for ease of use and may cause less simulator sickness, which often disrupts training. This makes it a more comfortable option for patients, offering a promising tool for relearning driving skills. ^{1 2 3 4 6}

Who Is on the Research Team?

Abiodun Akinwuntan, PhD, MPH MBA

Principal Investigator

University of Kansas School of Health Professions

Are You a Good Fit for This Trial?

This trial is for individuals with a first-ever stroke, Parkinson's disease (PD), or multiple sclerosis (MS) who have valid driver's licenses and at least 3 years of driving experience. They must score ≥24 on the Mini-mental State Examination and have binocular acuity meeting Kansas driving laws.

Inclusion Criteria

Mini-mental State Examination score ≥24, and

I have been diagnosed with stroke, Parkinson's disease, or multiple sclerosis for the first time.

I have a valid driver's license and over 3 years of driving experience.

Exclusion Criteria

I have a brain injury or another neurological condition, but not stroke, Parkinson's, or MS.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Pre-training Evaluation

Participants undergo driving-related physical, visual, and cognitive tests

1 week

1 visit (in-person)

Training

Participants receive five hours of simulator training to improve driving skills

2 weeks

5 visits (in-person)

Post-training Evaluation

Participants undergo a post-training evaluation similar to the pre-training evaluation

1 week

1 visit (in-person)

Follow-up

Participants are monitored for any long-term effects or improvements in driving skills

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Portable Driving Simulator

Trial Overview The study compares a low-cost portable driving simulator (PDS) to a high-fidelity fixed-base simulator in retraining driving skills. Participants will be randomly assigned to one of these tools for training and evaluated before and after the sessions.

How Is the Trial Designed?

Group I: Low-Fidelity PDS Training Experimental Treatment 1 Intervention

Individuals with stroke, PD, or MS

Group II: High Fidelity Fixed-Base Simulator Training Active Control 1 Intervention

Individuals with stroke, PD, or MS

Who Is Running the Clinical Trial?

University of Kansas Medical Center

Lead Sponsor

Trials

527

Recruited

181,000+

Published Research Related to This Trial

In a study involving 30 healthy subjects, the driving simulator (CRCDS Mini-Sim) effectively detected impairment in driving ability caused by 7.5 mg of zopiclone, a hypnotic medication.

The administration of zopiclone resulted in a significant increase in the standard deviation of lateral lane position (SDLP) by 2.62 cm, indicating impaired driving, which aligns closely with results from traditional on-the-road driving assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized, crossover, placebo-controlled clinical trial to assess the sensitivity of the CRCDS Mini-Sim to the next-day residual effects of zopiclone. Simen, AA., Gargano, C., Cha, JH., et al.[2020]

A study involving 56 neurological patients showed that the newly installed driving simulator at the Neurological Rehabilitation Centre was positively received, indicating good patient acceptance of this rehabilitation method.

Patients found the driving simulator to be motivating, effective, and informative, which is crucial for its successful implementation in assessing and rehabilitating driving ability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Interactive driving simulation--a new approach to diagnosis and rehabilitation of driving skills]. Wolbers, T., Küst, J., Karbe, H., et al.[2006]

A pilot study involving four drivers with Parkinson's disease showed that a rehabilitation program using a driving simulator led to a reduction in crashes and improved decision-making skills during simulated driving scenarios.

Three out of four participants demonstrated significant improvements in their driving performance on a standard road test after the training sessions, indicating that simulator training may be a beneficial intervention for drivers with Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

DRIVER REHABILITATION IN PARKINSON'S DISEASE USING A DRIVING SIMULATOR: A PILOT STUDY. Uc, E., Rizzo, M., Anderson, S., et al.[2021]

The driving simulator provides a safe and effective way to assess driving aptitude in patients with physical and cognitive deficits, showing a high correlation with real-world driving assessments (kappa=0.81; P<0.0001).

Medical experts tend to rely more on the results from the driving simulator than on neuropsychological evaluations, which have lower sensitivity and specificity (55% and 80% respectively), indicating that the simulator may offer a more accurate reflection of a patient's driving capabilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Relevance of a driving simulator in the assessment of handicapped individuals]. Carroz, A., Comte, PA., Nicolo, D., et al.[2019]

In a pilot study involving eight drivers with Parkinson's disease, a simulator training program showed a trend towards reduced crashes and significantly improved reaction times to potential crash risks over three driving sessions.

These results suggest that simulator training may be a feasible and beneficial intervention for improving driving safety in individuals with Parkinson's disease, warranting further research to explore its long-term effects and comparisons with standard driver education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

COLLISION AVOIDANCE TRAINING USING A DRIVING SIMULATOR IN DRIVERS WITH PARKINSON'S DISEASE: A PILOT STUDY. Dawson, JD., Rizzo, M., Anderson, SW., et al.[2021]

Patients deemed fit to drive after a traffic medical assessment performed worse on cognitive tests compared to established norms, indicating potential concerns about their driving fitness.

The CyberSiM driving simulator showed that a high percentage (75-95%) of patients fell within the suggested cut-off limits for driving ability, suggesting it may be a useful tool for assessing driving fitness alongside cognitive tests.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Usability of Norm Values on Results from a Simulator Device and Cognitive Tests in Traffic Medicine. Samuelsson, K., Wressle, E.[2022]

A pilot study involving 15 participants with Parkinson's disease showed that 10 hours of training in a high-fidelity driving simulator significantly improved on-road driving skills, with all participants who initially failed the road test passing after training.

Cognitive functions related to driving also improved, as evidenced by significant enhancements in scores on the Montreal Cognitive Assessment and the Dot Cancellation test, suggesting that simulator training may benefit both driving ability and cognitive skills in individuals with Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of a driving simulator to improve on-road driving performance and cognition in persons with Parkinson's disease: A pilot study. Devos, H., Morgan, JC., Onyeamaechi, A., et al.[2017]

A systematic review of 12 studies involving driving simulators for stroke patients identified three main categories of driving scenarios: vehicle controls, hazard perception, and trajectory planning, with simple navigation and emergency stop being the most common scenarios used.

The review highlights the need for future research to include more complex driving conditions, such as varying weather and localized traffic situations, to better assess the driving capabilities of stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Driving scenarios and environmental settings in simulator-based driving assessment systems for stroke: a systematic review. Chanmas, G., Taveekitworachai, P., Paliyawan, P., et al.[2023]

The study involving 91 neurological patients demonstrated that driving simulators can effectively differentiate between fit and unfit drivers based on reaction times and driving behaviors across various environments, highlighting their potential as assessment tools.

Unfit drivers showed significant issues such as greater variability in steering and more collisions in urban settings, while conditionally fit drivers did not exhibit clear differences from fit drivers, indicating the need for careful human judgment in their evaluation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring driving characteristics of fit- and unfit-to-drive neurological patients: a driving simulator study. Motnikar, L., Stojmenova, K., Štaba, UČ., et al.[2020]

A pilot study involving 22 individuals with acquired brain injury showed that eight sessions of driving simulator training, in addition to usual care, resulted in a significant increase in driver confidence compared to those receiving only usual care.

Despite the positive change in confidence, the simulator training did not lead to a significant improvement in on-road driving performance, with 50% of participants in the simulator group failing the on-road assessment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Investigating feasibility and preliminary efficacy of a simulator-based driving intervention for people with acquired brain injury: A randomised controlled pilot study. Dimech-Betancourt, B., Ponsford, JL., Charlton, JL., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03969927

User-friendliness of a Portable Driving Simulator | ... The use of simulators to retrain driving skills of patients with stroke, Parkinson's disease (PD), or multiple sclerosis (MS) is very limited because of ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0003999325001728

User-friendliness of a Portable Driving Simulator to Retrain ... To compare the benefits of retraining impaired driving skills of persons with MS and PD using the PDS and a high-fidelity simulator (HFS).

3. app.trialscreen.org app.trialscreen.org/trials/parkinson-disease-user-friendliness-portable-driving-simulator-trial-nct03969927

User-friendliness of a Portable Driving Simulator Study Design. The study involves 30 participants with stroke, Parkinson's disease, or multiple sclerosis, randomly assigned to either the PDS ...

4. withpower.com withpower.com/trial/phase-parkinson-disease-7-2019-dde46

Portable Driving Simulator for Neurological Conditions Research shows that driving simulators can be effective in improving driving skills and cognitive functions in people with neurological conditions like ...

5. clinicaltrial.be clinicaltrial.be/en/details/82170?per_page=100&only_recruiting=0&only_eligible=0&only_active=0

User-friendliness of a Portable Driving Simulator - Clini... ... driving-related skills after stroke and with promise in individuals with Parkinson's disease (PD) or multiple sclerosis (MS). Driving ...

6. smartpatients.com smartpatients.com/trials/NCT03969927

User-friendliness of a Portable Driving Simulator The use of simulators to retrain driving skills of patients with stroke, Parkinson's disease (PD), or multiple sclerosis (MS) is very limited because of cost, ...